FDA grants EUA to Pfizer-BioNTech COVID-19 vaccine for use in children 5-11

Nov. 1, 2021

The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5-11 years old.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will take up the issue at its meeting November 2. CDC action on the issue is required before healthcare providers can begin providing the vaccine to children.

The FDA said the authorization was “based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.”

The vaccine’s safety was studied in approximately 3,100 children 5-11 years old who received the vaccine and no serious side effects have been detected in the ongoing study.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock, MD.

The Pfizer-BioNTech COVID-19 vaccine for children 5-11 years old is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

In the U.S., COVID-19 cases in children 5-11 years old make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in children 5-11 years old. 

The effectiveness data to support the EUA in children down to 5 years of age is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children 5-11 years old. The study is being conducted in the U.S., Finland, Poland and Spain. Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 Vaccine containing 10 micrograms of messenger RNA per dose. The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune responses of the younger age participants were comparable to the older participants.

The FDA also conducted a preliminary analysis of cases of COVID-19 occurring seven days after the second dose. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, 3 cases of COVID-19 occurred among 1,305 vaccine recipients and 16 cases of COVID-19 occurred among 663 placebo recipients; the vaccine was 90.7% effective in preventing COVID-19.

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